Athera Biotechnologies AB announced today that the the U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to the fully human antibody PC-mAb, for the treatment of patients with end stage renal disease, who are preparing for or undergo hemodialysis, to prevent vascular access failure.

“We are pleased that the FDA have granted orphan drug designation to our therapeutic candidate PC-mAb.” says Carina Schmidt, CEO of Athera. “The granting highlights the great unmet medical need for new therapies for kidney disease patients, who are dependent on a well-functioning vascular access for their hemodialysis.”

End stage renal disease (ESRD) patients have a loss of kidney function and require either dialysis or a kidney transplant to survive. All patients on hemodialysis require a reliable vascular access. It has been estimated that 20% of all hospitalizations in the hemodialysis population are due to vascular access dysfunction. Creation of a well-functioning vascular access is a main concern, as complications substantially contribute to morbidity and mortality. PC-mAb reduces inflammation by targeting PC (phosphorylcholine), and therefore has the potential to prevent the neointimal hyperplasia that is the root cause of vascular access failure. The fully human PC-mAb is designed to mimic the anti-inflammatory role of endogenous antibodies against PC and act to support the immune response to vascular inflammation challenges and thereby reduce the risk for complications.